RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "71241-004-94",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-004-94)  > 95 g in 1 BOTTLE, PUMP (71241-004-95) ",
      "NDC11Code": "71241-0004-94",
      "ProductNDC": "71241-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel",
      "NonProprietaryName": "Avobenzone,homosalate,meradimate,octisalate,octocrylene",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20211101",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sientra, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20211101",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "14498-004-01",
      "PackageDescription": "1 KIT in 1 KIT (14498-004-01)  / 29 mL in 1 KIT",
      "NDC11Code": "14498-0004-01",
      "ProductNDC": "14498-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sterile Cord Blood Collection Unit (msc128d)",
      "NonProprietaryName": "Anticoagulant Citrate Phosphate Dextrose Solution",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161221",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "BN125552",
      "LabelerName": "Maco Productions",
      "SubstanceName": "SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE",
      "StrengthNumber": ".76; .74; 94.8; 72.8",
      "StrengthUnit": "g/29mL; g/29mL; mg/29mL; mg/29mL",
      "Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20161221",
      "SamplePackage": "N",
      "IndicationAndUsage": "MSC128D - For collection of up to 200 mL of umbilical cord blood. Use aseptic technique.",
      "Description": "The MSC128D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 21 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), a 40 mL rinsing bag containing 8 mL of CPD and two 12 gauge needles with a protective shield (SECUVAM) for the used needle. Sterile, non-pyrogenic fluid path. Sterilized by steam. Rx only. This product is not made with natural rubber latex."
    },
    {
      "NDCCode": "24562-004-30",
      "PackageDescription": "30 mL in 1 VIAL, GLASS (24562-004-30) ",
      "NDC11Code": "24562-0004-30",
      "ProductNDC": "24562-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ammonia N 13",
      "NonProprietaryName": "Ammonia N-13",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20150514",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA204352",
      "LabelerName": "Biomedical Research Foundation of Northwest Louisiana",
      "SubstanceName": "AMMONIA N-13",
      "StrengthNumber": "37.5",
      "StrengthUnit": "mCi/mL",
      "Pharm_Classes": "Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-06-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20150514",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.",
      "Description": "Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3with a molecular weight of 16.02, and has the following chemical structure. Ammonia N 13 Injection, USP is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride solution. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia."
    },
    {
      "NDCCode": "43674-004-02",
      "PackageDescription": "2 BLISTER PACK in 1 CARTON (43674-004-02)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "43674-0004-02",
      "ProductNDC": "43674-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Rezenopy",
      "NonProprietaryName": "Naloxone Hydrochloride",
      "DosageFormName": "SPRAY",
      "RouteName": "NASAL",
      "StartMarketingDate": "20250210",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA215487",
      "LabelerName": "Summit Biosciences Inc",
      "SubstanceName": "NALOXONE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/.11mL",
      "Pharm_Classes": "Opioid Antagonist [EPC], Opioid Antagonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20250210",
      "SamplePackage": "N",
      "IndicationAndUsage": "REZENOPY nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care.",
      "Description": "REZENOPY (naloxone hydrochloride) nasal spray is a pre-filled, single dose intranasal spray. Chemically, naloxone hydrochloride is the hydrochloride salt of 17-Allyl-4,5α-epoxy- 3,14-dihydroxymorphinan-6-one hydrochloride with the following structure. Molecular Formula: C19H21N04HCl2H20Relative Molecular Mass: 399.87. Naloxone hydrochloride, an opioid antagonist, occurs as a white, to slightly off-white powder or almost white crystalline powder and contains two molecules of water of hydration. It is freely soluble in water, in dilute acids, and in strong alkali; slightly soluble in ethanol. pKa values (proton on Nitrogen) are respectively 7.94 at 20°C and 7.82 at 37°C. Each REZENOPY nasal spray delivers 10 mg naloxone hydrochloride (equivalent to 9 mg of naloxone) in a 0.11 mL aqueous solution. Inactive ingredients include glycerin, trisodium citrate dihydrate, hydrochloric acid and sodium hydroxide to adjust pH, and purified water. The pH range is 3.9 to 4.5."
    },
    {
      "NDCCode": "51655-004-20",
      "PackageDescription": "20 CAPSULE in 1 BOTTLE, PLASTIC (51655-004-20) ",
      "NDC11Code": "51655-0004-20",
      "ProductNDC": "51655-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065470",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250313",
      "SamplePackage": "N",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms.             Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.             Respiratory tract infections caused by Mycoplasma pneumoniae.             Lymphogranuloma venereum caused by Chlamydia trachomatis.             Psittacosis (Ornithosis) due to Chlamydophila psittaci.             Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.             Inclusion conjunctivitis caused by Chlamydia trachomatis.             Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticumor Chlamydia trachomatis.             Relapsing fever due to Borrelia recurrentis.             Chancroid caused by Haemophilus ducreyi.             Plague due to Yersinia pestis.             Tularemia due to Francisella tularensis.             Cholera caused by Vibrio cholerae.             Campylobacter fetus infections caused by Campylobacter fetus.             Brucellosis due to Brucellaspecies (in conjunction with streptomycin).             Bartonellosis due to Bartonella bacilliformis.             Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Escherichia coli.             Klebsiella aerogenes.             Shigellaspecies.             Acinetobacterspecies.             Respiratory tract infections caused by Haemophilus influenzae.             Respiratory tract and urinary tract infections caused by Klebsiellaspecies. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Upper respiratory tract infections caused by Streptococcus pneumoniae.             Skin and skin structure infections caused by Staphylococcus aureus.(NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections.             Uncomplicated urethritis in men due to Neisseria gonorrhoeaeand for the treatment of other gonococcal infections.             Infections in women caused by Neisseria gonorrhoeae.             Syphilis caused by Treponema pallidumsubspecies pallidum.             Yaws caused by Treponema pallidumsubspecies pertenue.             Listeriosis due to Listeria monocytogenes.             Anthrax due to Bacillus anthracis.             Vincent's infection caused by Fusobacterium fusiforme.             Actinomycosis caused by Actinomyces israelii.             Infections caused by Clostridiumspecies. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidisto eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C 23H 27N 3O 7HCl                                             M.W. 493.94. Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3, D&C Red #33, and FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and red iron oxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "51655-004-52",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE, DISPENSING (51655-004-52) ",
      "NDC11Code": "51655-0004-52",
      "ProductNDC": "51655-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Minocycline Hydrochloride",
      "NonProprietaryName": "Minocycline Hydrochloride",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140820",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA065470",
      "LabelerName": "Northwind Health Company, LLC",
      "SubstanceName": "MINOCYCLINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]",
      "Status": "Active",
      "LastUpdate": "2026-02-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20140820",
      "SamplePackage": "N",
      "IndicationAndUsage": "Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms.             Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.             Respiratory tract infections caused by Mycoplasma pneumoniae.             Lymphogranuloma venereum caused by Chlamydia trachomatis.             Psittacosis (Ornithosis) due to Chlamydophila psittaci.             Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.             Inclusion conjunctivitis caused by Chlamydia trachomatis.             Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticumor Chlamydia trachomatis.             Relapsing fever due to Borrelia recurrentis.             Chancroid caused by Haemophilus ducreyi.             Plague due to Yersinia pestis.             Tularemia due to Francisella tularensis.             Cholera caused by Vibrio cholerae.             Campylobacter fetus infections caused by Campylobacter fetus.             Brucellosis due to Brucellaspecies (in conjunction with streptomycin).             Bartonellosis due to Bartonella bacilliformis.             Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Escherichia coli.             Klebsiella aerogenes.             Shigellaspecies.             Acinetobacterspecies.             Respiratory tract infections caused by Haemophilus influenzae.             Respiratory tract and urinary tract infections caused by Klebsiellaspecies. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Upper respiratory tract infections caused by Streptococcus pneumoniae.             Skin and skin structure infections caused by Staphylococcus aureus.(NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections.             Uncomplicated urethritis in men due to Neisseria gonorrhoeaeand for the treatment of other gonococcal infections.             Infections in women caused by Neisseria gonorrhoeae.             Syphilis caused by Treponema pallidumsubspecies pallidum.             Yaws caused by Treponema pallidumsubspecies pertenue.             Listeriosis due to Listeria monocytogenes.             Anthrax due to Bacillus anthracis.             Vincent's infection caused by Fusobacterium fusiforme.             Actinomycosis caused by Actinomyces israelii.             Infections caused by Clostridiumspecies. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidisto eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
      "Description": "Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C 23H 27N 3O 7HCl                                             M.W. 493.94. Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3, D&C Red #33, and FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and red iron oxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide."
    },
    {
      "NDCCode": "62332-004-90",
      "PackageDescription": "90 TABLET in 1 BOTTLE (62332-004-90) ",
      "NDC11Code": "62332-0004-90",
      "ProductNDC": "62332-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Pramipexole Dihydrochloride",
      "NonProprietaryName": "Pramipexole Dihydrochloride",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160322",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078894",
      "LabelerName": "Alembic Pharmaceuticals Inc.",
      "SubstanceName": "PRAMIPEXOLE DIHYDROCHLORIDE",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160322",
      "SamplePackage": "N",
      "IndicationAndUsage": "Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).",
      "Description": "Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone."
    },
    {
      "NDCCode": "74204-004-01",
      "PackageDescription": "118.3 mL in 1 BOTTLE, PLASTIC (74204-004-01) ",
      "NDC11Code": "74204-0004-01",
      "ProductNDC": "74204-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nelsons Green Brier Hand Rub",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200417",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Nelson's Green Brier Distillery, LLC",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "94.64",
      "StrengthUnit": "mL/118.3mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-07-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20200417",
      "SamplePackage": "N",
      "IndicationAndUsage": "Health care personnel hand rub to help reduce bacteria that potentially can cause disease."
    },
    {
      "NDCCode": "78740-004-04",
      "PackageDescription": "400 mL in 1 CANISTER (78740-004-04) ",
      "NDC11Code": "78740-0004-04",
      "ProductNDC": "78740-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ivresse Sanitizer Disinfectant",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200811",
      "EndMarketingDate": "20250401",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333E",
      "LabelerName": "Ivresse Internacional, S.A. de C.V.",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": ".94",
      "StrengthUnit": "mL/mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200811",
      "EndMarketingDatePackage": "20250401",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps reduce bacteria on the skin. Recommended for repeated use."
    },
    {
      "NDCCode": "80933-004-01",
      "PackageDescription": "100 kg in 1 DRUM (80933-004-01) ",
      "NDC11Code": "80933-0004-01",
      "ProductNDC": "80933-004",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200715",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Package Kare Inc., D.B.A. Advanced Powder Solutions",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "94",
      "StrengthUnit": "kg/100kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-29",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "15-JUL-20"
    },
    {
      "NDCCode": "80933-004-02",
      "PackageDescription": "150 kg in 1 DRUM (80933-004-02) ",
      "NDC11Code": "80933-0004-02",
      "ProductNDC": "80933-004",
      "ProductTypeName": "DRUG FOR FURTHER PROCESSING",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20200715",
      "MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
      "LabelerName": "Package Kare Inc., D.B.A. Advanced Powder Solutions",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "94",
      "StrengthUnit": "kg/100kg",
      "Status": "Unfinished",
      "LastUpdate": "2025-10-29",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "15-JUL-20"
    },
    {
      "NDCCode": "82449-004-01",
      "PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01)  / 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "82449-0004-01",
      "ProductNDC": "82449-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziprasidone Mesylate",
      "NonProprietaryName": "Ziprasidone Mesylate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20251219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217595",
      "LabelerName": "STERISCIENCE SPECIALTIES PRIVATE LIMITED",
      "SubstanceName": "ZIPRASIDONE MESYLATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)] .",
      "Description": "Ziprasidone mesylate for injection is an atypical antipsychotic as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C 21H 21ClN 4OS ∙ CH 3SO 3H ∙ 3H 2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [ see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
    },
    {
      "NDCCode": "82449-004-02",
      "PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02)  / 1 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "82449-0004-02",
      "ProductNDC": "82449-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ziprasidone Mesylate",
      "NonProprietaryName": "Ziprasidone Mesylate",
      "DosageFormName": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
      "RouteName": "INTRAMUSCULAR",
      "StartMarketingDate": "20251219",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217595",
      "LabelerName": "STERISCIENCE SPECIALTIES PRIVATE LIMITED",
      "SubstanceName": "ZIPRASIDONE MESYLATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Atypical Antipsychotic [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-12-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251219",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)] .",
      "Description": "Ziprasidone mesylate for injection is an atypical antipsychotic as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C 21H 21ClN 4OS ∙ CH 3SO 3H ∙ 3H 2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [ see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD)."
    },
    {
      "NDCCode": "83257-004-12",
      "PackageDescription": "1 KIT in 1 CARTON (83257-004-12)  *  20 mL in 1 VIAL, MULTI-DOSE (83257-003-11)  *  20 mL in 1 VIAL (83257-002-11) ",
      "NDC11Code": "83257-0004-12",
      "ProductNDC": "83257-004",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ogivri",
      "NonProprietaryName": "Trastuzumab-dkst",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20231001",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761074",
      "LabelerName": "Biocon Biologics Inc.",
      "Status": "Active",
      "LastUpdate": "2026-08-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20231001",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).",
      "Description": "Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg).  Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg).  Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer.  Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6."
    },
    {
      "NDCCode": "71241-001-01",
      "PackageDescription": "1 TUBE in 1 CARTON (71241-001-01)  > 1 g in 1 TUBE (71241-001-96) ",
      "NDC11Code": "71241-0001-01",
      "ProductNDC": "71241-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Octinoxate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SIENTRA, INC.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "7.5; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
    },
    {
      "NDCCode": "71241-001-10",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-001-10)  > 10 g in 1 BOTTLE, PUMP (71241-001-97) ",
      "NDC11Code": "71241-0001-10",
      "ProductNDC": "71241-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Octinoxate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SIENTRA, INC.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "7.5; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
    },
    {
      "NDCCode": "71241-001-20",
      "PackageDescription": "20 g in 1 BOTTLE, PUMP (71241-001-20) ",
      "NDC11Code": "71241-0001-20",
      "ProductNDC": "71241-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Octinoxate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SIENTRA, INC.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "7.5; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-20",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "71241-001-50",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-001-50)  > 50 g in 1 BOTTLE, PUMP (71241-001-99) ",
      "NDC11Code": "71241-0001-50",
      "ProductNDC": "71241-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Octinoxate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160309",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SIENTRA, INC.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "7.5; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
    },
    {
      "NDCCode": "71241-001-98",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-001-98)  > 20 g in 1 BOTTLE, PUMP (71241-001-20) ",
      "NDC11Code": "71241-0001-98",
      "ProductNDC": "71241-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Octinoxate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170301",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "SIENTRA, INC.",
      "SubstanceName": "OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "7.5; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20170301",
      "SamplePackage": "N",
      "IndicationAndUsage": "BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands)."
    },
    {
      "NDCCode": "71241-002-99",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-002-99)  > 5 g in 1 BOTTLE, PUMP (71241-002-05) ",
      "NDC11Code": "71241-0002-99",
      "ProductNDC": "71241-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Advanced Scar Treatment Anti-itch",
      "NonProprietaryName": "Hydrocortisone Acetate 1%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20180508",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part348",
      "LabelerName": "Sientra, Inc.",
      "SubstanceName": "HYDROCORTISONE ACETATE",
      "StrengthNumber": "1",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180508",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71241-003-96",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-003-96)  > 1 g in 1 BOTTLE, PUMP (71241-003-01) ",
      "NDC11Code": "71241-0003-96",
      "ProductNDC": "71241-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sientra, Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71241-003-97",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-003-97)  > 10 g in 1 BOTTLE, PUMP (71241-003-10) ",
      "NDC11Code": "71241-0003-97",
      "ProductNDC": "71241-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sientra, Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-12-29",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71241-003-98",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-003-98)  > 20 g in 1 BOTTLE, PUMP (71241-003-20) ",
      "NDC11Code": "71241-0003-98",
      "ProductNDC": "71241-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sientra, Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "71241-003-99",
      "PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (71241-003-99)  > 50 g in 1 BOTTLE, PUMP (71241-003-50) ",
      "NDC11Code": "71241-0003-99",
      "ProductNDC": "71241-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "NonProprietaryName": "Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200331",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Sientra, Inc",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 15; 5; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20200331",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "0004-0086-94",
      "PackageDescription": "168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94) ",
      "NDC11Code": "00004-0086-94",
      "ProductNDC": "0004-0086",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Copegus",
      "NonProprietaryName": "Ribavirin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20021203",
      "EndMarketingDate": "20180131",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021511",
      "LabelerName": "Genentech, Inc.",
      "SubstanceName": "RIBAVIRIN",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2018-02-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "0024-5908-01",
      "PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-01)  / 1.14 mL in 1 SYRINGE (0024-5908-00) ",
      "NDC11Code": "00024-5908-01",
      "ProductNDC": "0024-5908",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kevzara",
      "NonProprietaryName": "Sarilumab",
      "DosageFormName": "INJECTION, SOLUTION",
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      "StartMarketingDate": "20170522",
      "MarketingCategoryName": "BLA",
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      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "SARILUMAB",
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      "Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
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      "LastUpdate": "2026-03-11",
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      "ProductNdcExcludeFlag": "N",
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      "EndMarketingDatePackage": "20270430",
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      "Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
    },
    {
      "NDCCode": "0024-5908-02",
      "PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5908-02)  / 1.14 mL in 1 SYRINGE",
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      "ProductNDC": "0024-5908",
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      "DosageFormName": "INJECTION, SOLUTION",
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      "MarketingCategoryName": "BLA",
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      "Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
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      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170522",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
      "Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
    },
    {
      "NDCCode": "0024-5910-01",
      "PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5910-01)  / 1.14 mL in 1 SYRINGE (0024-5910-00) ",
      "NDC11Code": "00024-5910-01",
      "ProductNDC": "0024-5910",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kevzara",
      "NonProprietaryName": "Sarilumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20170522",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761037",
      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "SARILUMAB",
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      "StrengthUnit": "mg/1.14mL",
      "Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170522",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
      "Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
    },
    {
      "NDCCode": "0024-5910-02",
      "PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5910-02)  / 1.14 mL in 1 SYRINGE",
      "NDC11Code": "00024-5910-02",
      "ProductNDC": "0024-5910",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kevzara",
      "NonProprietaryName": "Sarilumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20170522",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761037",
      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "SARILUMAB",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1.14mL",
      "Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20170522",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
      "Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
    },
    {
      "NDCCode": "0024-5920-01",
      "PackageDescription": "2 SYRINGE in 1 PACKAGE (0024-5920-01)  / 1.14 mL in 1 SYRINGE (0024-5920-00) ",
      "NDC11Code": "00024-5920-01",
      "ProductNDC": "0024-5920",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kevzara",
      "NonProprietaryName": "Sarilumab",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "SUBCUTANEOUS",
      "StartMarketingDate": "20170522",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA761037",
      "LabelerName": "Sanofi-Aventis U.S. LLC",
      "SubstanceName": "SARILUMAB",
      "StrengthNumber": "150",
      "StrengthUnit": "mg/1.14mL",
      "Pharm_Classes": "Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-03-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20180413",
      "SamplePackage": "N",
      "IndicationAndUsage": "KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).",
      "Description": "Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP."
    }
  ]
}
                    

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<NDCList>
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    <NDCCode>71241-004-94</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-004-94)  &gt; 95 g in 1 BOTTLE, PUMP (71241-004-95) </PackageDescription>
    <NDC11Code>71241-0004-94</NDC11Code>
    <ProductNDC>71241-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel</ProprietaryName>
    <NonProprietaryName>Avobenzone,homosalate,meradimate,octisalate,octocrylene</NonProprietaryName>
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    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20211101</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sientra, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>14498-004-01</NDCCode>
    <PackageDescription>1 KIT in 1 KIT (14498-004-01)  / 29 mL in 1 KIT</PackageDescription>
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    <ProductNDC>14498-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sterile Cord Blood Collection Unit (msc128d)</ProprietaryName>
    <NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Solution</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>BN125552</ApplicationNumber>
    <LabelerName>Maco Productions</LabelerName>
    <SubstanceName>SODIUM CITRATE; DEXTROSE MONOHYDRATE; CITRIC ACID MONOHYDRATE; SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE</SubstanceName>
    <StrengthNumber>.76; .74; 94.8; 72.8</StrengthNumber>
    <StrengthUnit>g/29mL; g/29mL; mg/29mL; mg/29mL</StrengthUnit>
    <Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
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    <LastUpdate>2025-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>MSC128D - For collection of up to 200 mL of umbilical cord blood. Use aseptic technique.</IndicationAndUsage>
    <Description>The MSC128D Sterile Cord Blood Collection Unit consists of 300 mL collection bag containing 21 mL of Anticoagulant Citrate Phosphate Dextrose Solution USP (CPD), a 40 mL rinsing bag containing 8 mL of CPD and two 12 gauge needles with a protective shield (SECUVAM) for the used needle. Sterile, non-pyrogenic fluid path. Sterilized by steam. Rx only. This product is not made with natural rubber latex.</Description>
  </NDC>
  <NDC>
    <NDCCode>24562-004-30</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, GLASS (24562-004-30) </PackageDescription>
    <NDC11Code>24562-0004-30</NDC11Code>
    <ProductNDC>24562-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ammonia N 13</ProprietaryName>
    <NonProprietaryName>Ammonia N-13</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20150514</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA204352</ApplicationNumber>
    <LabelerName>Biomedical Research Foundation of Northwest Louisiana</LabelerName>
    <SubstanceName>AMMONIA N-13</SubstanceName>
    <StrengthNumber>37.5</StrengthNumber>
    <StrengthUnit>mCi/mL</StrengthUnit>
    <Pharm_Classes>Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20150514</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ammonia N 13 Injection, USP is indicated for diagnostic Positron Emission Tomography (PET) imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.</IndicationAndUsage>
    <Description>Ammonia N 13 Injection, USP is a positron emitting radiopharmaceutical that is used for diagnostic purposes in conjunction with positron emission tomography (PET) imaging. The active ingredient, [13N] ammonia, has the molecular formula of 13NH3with a molecular weight of 16.02, and has the following chemical structure. Ammonia N 13 Injection, USP is provided as a ready to use sterile, pyrogen-free, clear and colorless solution. Each mL of the solution contains between 0.138 GBq to 1.387 GBq (3.75 mCi to 37.5 mCi) of [13N] ammonia, at the end of synthesis (EOS) reference time, in 0.9% aqueous sodium chloride solution. The pH of the solution is between 4.5 to 7.5. The recommended dose of radioactivity (10-20 mCi) is associated with a theoretical mass dose of 0.5-1.0 picomoles (8.47-16.94 picograms) of ammonia.</Description>
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  <NDC>
    <NDCCode>43674-004-02</NDCCode>
    <PackageDescription>2 BLISTER PACK in 1 CARTON (43674-004-02)  / 1 VIAL, SINGLE-DOSE in 1 BLISTER PACK / .11 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>43674-0004-02</NDC11Code>
    <ProductNDC>43674-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Rezenopy</ProprietaryName>
    <NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>NASAL</RouteName>
    <StartMarketingDate>20250210</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA215487</ApplicationNumber>
    <LabelerName>Summit Biosciences Inc</LabelerName>
    <SubstanceName>NALOXONE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/.11mL</StrengthUnit>
    <Pharm_Classes>Opioid Antagonist [EPC], Opioid Antagonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250210</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>REZENOPY nasal spray is indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. REZENOPY nasal spray is intended for immediate administration as emergency therapy in settings where opioids may be present. REZENOPY nasal spray is not a substitute for emergency medical care.</IndicationAndUsage>
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  <NDC>
    <NDCCode>51655-004-20</NDCCode>
    <PackageDescription>20 CAPSULE in 1 BOTTLE, PLASTIC (51655-004-20) </PackageDescription>
    <NDC11Code>51655-0004-20</NDC11Code>
    <ProductNDC>51655-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Minocycline Hydrochloride</ProprietaryName>
    <NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140820</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA065470</ApplicationNumber>
    <LabelerName>Northwind Health Company, LLC</LabelerName>
    <SubstanceName>MINOCYCLINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250313</StartMarketingDatePackage>
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    <IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms.             Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.             Respiratory tract infections caused by Mycoplasma pneumoniae.             Lymphogranuloma venereum caused by Chlamydia trachomatis.             Psittacosis (Ornithosis) due to Chlamydophila psittaci.             Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.             Inclusion conjunctivitis caused by Chlamydia trachomatis.             Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticumor Chlamydia trachomatis.             Relapsing fever due to Borrelia recurrentis.             Chancroid caused by Haemophilus ducreyi.             Plague due to Yersinia pestis.             Tularemia due to Francisella tularensis.             Cholera caused by Vibrio cholerae.             Campylobacter fetus infections caused by Campylobacter fetus.             Brucellosis due to Brucellaspecies (in conjunction with streptomycin).             Bartonellosis due to Bartonella bacilliformis.             Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Escherichia coli.             Klebsiella aerogenes.             Shigellaspecies.             Acinetobacterspecies.             Respiratory tract infections caused by Haemophilus influenzae.             Respiratory tract and urinary tract infections caused by Klebsiellaspecies. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Upper respiratory tract infections caused by Streptococcus pneumoniae.             Skin and skin structure infections caused by Staphylococcus aureus.(NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections.             Uncomplicated urethritis in men due to Neisseria gonorrhoeaeand for the treatment of other gonococcal infections.             Infections in women caused by Neisseria gonorrhoeae.             Syphilis caused by Treponema pallidumsubspecies pallidum.             Yaws caused by Treponema pallidumsubspecies pertenue.             Listeriosis due to Listeria monocytogenes.             Anthrax due to Bacillus anthracis.             Vincent's infection caused by Fusobacterium fusiforme.             Actinomycosis caused by Actinomyces israelii.             Infections caused by Clostridiumspecies. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidisto eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C 23H 27N 3O 7HCl                                             M.W. 493.94. Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&amp;C Red #3, D&amp;C Red #33, and FD&amp;C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&amp;C Blue #1, D&amp;C Red #28, FD&amp;C Red #40, and red iron oxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>51655-004-52</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE, DISPENSING (51655-004-52) </PackageDescription>
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    <ProductNDC>51655-004</ProductNDC>
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    <LabelerName>Northwind Health Company, LLC</LabelerName>
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    <Pharm_Classes>Decreased Prothrombin Activity [PE], Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
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    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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    <StartMarketingDatePackage>20140820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms.             Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.             Respiratory tract infections caused by Mycoplasma pneumoniae.             Lymphogranuloma venereum caused by Chlamydia trachomatis.             Psittacosis (Ornithosis) due to Chlamydophila psittaci.             Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.             Inclusion conjunctivitis caused by Chlamydia trachomatis.             Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticumor Chlamydia trachomatis.             Relapsing fever due to Borrelia recurrentis.             Chancroid caused by Haemophilus ducreyi.             Plague due to Yersinia pestis.             Tularemia due to Francisella tularensis.             Cholera caused by Vibrio cholerae.             Campylobacter fetus infections caused by Campylobacter fetus.             Brucellosis due to Brucellaspecies (in conjunction with streptomycin).             Bartonellosis due to Bartonella bacilliformis.             Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Escherichia coli.             Klebsiella aerogenes.             Shigellaspecies.             Acinetobacterspecies.             Respiratory tract infections caused by Haemophilus influenzae.             Respiratory tract and urinary tract infections caused by Klebsiellaspecies. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug.             Upper respiratory tract infections caused by Streptococcus pneumoniae.             Skin and skin structure infections caused by Staphylococcus aureus.(NOTE: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections.             Uncomplicated urethritis in men due to Neisseria gonorrhoeaeand for the treatment of other gonococcal infections.             Infections in women caused by Neisseria gonorrhoeae.             Syphilis caused by Treponema pallidumsubspecies pallidum.             Yaws caused by Treponema pallidumsubspecies pertenue.             Listeriosis due to Listeria monocytogenes.             Anthrax due to Bacillus anthracis.             Vincent's infection caused by Fusobacterium fusiforme.             Actinomycosis caused by Actinomyces israelii.             Infections caused by Clostridiumspecies. In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides. In severe acne, minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidisto eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection. Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum. To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
    <Description>Minocycline hydrochloride, USP, is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride. Its structural formula is:. C 23H 27N 3O 7HCl                                             M.W. 493.94. Minocycline hydrochloride capsules, USP for oral administration contain minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of minocycline. The capsule also contains the following inactive ingredients: corn starch and magnesium stearate. The empty hard gelatin capsule shells contain titanium dioxide, sodium lauryl sulfate, and gelatin. In addition, the 50 mg capsule shells contain FD&amp;C Red #3, D&amp;C Red #33, and FD&amp;C Yellow #6; the 75 mg capsule shells contain black iron oxide; and the 100 mg capsule shells contain FD&amp;C Blue #1, D&amp;C Red #28, FD&amp;C Red #40, and red iron oxide. The capsules are printed with edible ink containing shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>62332-004-90</NDCCode>
    <PackageDescription>90 TABLET in 1 BOTTLE (62332-004-90) </PackageDescription>
    <NDC11Code>62332-0004-90</NDC11Code>
    <ProductNDC>62332-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName>
    <NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160322</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078894</ApplicationNumber>
    <LabelerName>Alembic Pharmaceuticals Inc.</LabelerName>
    <SubstanceName>PRAMIPEXOLE DIHYDROCHLORIDE</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Dopamine Agonists [MoA], Nonergot Dopamine Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Pramipexole dihydrochloride tablets are non-ergot dopamine agonist indicated for the treatment of.  Parkinson’s disease (PD) (1.1)  Moderate-to-severe primary Restless Legs Syndrome (RLS) (1.2).</IndicationAndUsage>
    <Description>Pramipexole dihydrochloride tablets contain pramipexole, a nonergot dopamine agonist. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino) benzothiazole dihydrochloride monohydrate. Its empirical formula is C10 H17 N3 S · 2HCl · H2O, and its molecular weight is 302.26. The structural formula is. Pramipexole dihydrochloride is a white to off-white powder substance. Melting occurs in the range of 296°C to 301°C, with decomposition. Pramipexole dihydrochloride is more than 20% soluble in water, about 8% in methanol, about 0.5% in ethanol, and practically insoluble in dichloromethane. Pramipexole dihydrochloride tablets 0.125 mg. Each tablet contains 0.125 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.118 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.25 mg. Each tablet contains 0.25 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.235 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 0.5 mg. Each tablet contains 0.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.47 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1 mg. Each tablet contains 1 mg pramipexole dihydrochloride monohydrate, USP equivalent to 0.94 mg pramipexole dihydrochloride. Pramipexole dihydrochloride tablets 1.5 mg. Each tablet contains 1.5 mg pramipexole dihydrochloride monohydrate, USP equivalent to 1.41 mg pramipexole dihydrochloride. Inactive ingredients consist of betacyclodextrin (betadex), colloidal silicon dioxide, corn starch, magnesium stearate, microcrystalline cellulose and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>74204-004-01</NDCCode>
    <PackageDescription>118.3 mL in 1 BOTTLE, PLASTIC (74204-004-01) </PackageDescription>
    <NDC11Code>74204-0004-01</NDC11Code>
    <ProductNDC>74204-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nelsons Green Brier Hand Rub</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200417</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Nelson's Green Brier Distillery, LLC</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>94.64</StrengthNumber>
    <StrengthUnit>mL/118.3mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-07-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200417</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Health care personnel hand rub to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>78740-004-04</NDCCode>
    <PackageDescription>400 mL in 1 CANISTER (78740-004-04) </PackageDescription>
    <NDC11Code>78740-0004-04</NDC11Code>
    <ProductNDC>78740-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ivresse Sanitizer Disinfectant</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200811</StartMarketingDate>
    <EndMarketingDate>20250401</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333E</ApplicationNumber>
    <LabelerName>Ivresse Internacional, S.A. de C.V.</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>.94</StrengthNumber>
    <StrengthUnit>mL/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200811</StartMarketingDatePackage>
    <EndMarketingDatePackage>20250401</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps reduce bacteria on the skin. Recommended for repeated use.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80933-004-01</NDCCode>
    <PackageDescription>100 kg in 1 DRUM (80933-004-01) </PackageDescription>
    <NDC11Code>80933-0004-01</NDC11Code>
    <ProductNDC>80933-004</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200715</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Package Kare Inc., D.B.A. Advanced Powder Solutions</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>94</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-JUL-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>80933-004-02</NDCCode>
    <PackageDescription>150 kg in 1 DRUM (80933-004-02) </PackageDescription>
    <NDC11Code>80933-0004-02</NDC11Code>
    <ProductNDC>80933-004</ProductNDC>
    <ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20200715</StartMarketingDate>
    <MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
    <LabelerName>Package Kare Inc., D.B.A. Advanced Powder Solutions</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>94</StrengthNumber>
    <StrengthUnit>kg/100kg</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2025-10-29</LastUpdate>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>15-JUL-20</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>82449-004-01</NDCCode>
    <PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-01)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>82449-0004-01</NDC11Code>
    <ProductNDC>82449-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone Mesylate</ProprietaryName>
    <NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20251219</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217595</ApplicationNumber>
    <LabelerName>STERISCIENCE SPECIALTIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ZIPRASIDONE MESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)] .</IndicationAndUsage>
    <Description>Ziprasidone mesylate for injection is an atypical antipsychotic as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C 21H 21ClN 4OS ∙ CH 3SO 3H ∙ 3H 2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [ see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
  </NDC>
  <NDC>
    <NDCCode>82449-004-02</NDCCode>
    <PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (82449-004-02)  / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>82449-0004-02</NDC11Code>
    <ProductNDC>82449-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ziprasidone Mesylate</ProprietaryName>
    <NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName>
    <DosageFormName>INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION</DosageFormName>
    <RouteName>INTRAMUSCULAR</RouteName>
    <StartMarketingDate>20251219</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217595</ApplicationNumber>
    <LabelerName>STERISCIENCE SPECIALTIES PRIVATE LIMITED</LabelerName>
    <SubstanceName>ZIPRASIDONE MESYLATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-12-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251219</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ziprasidone mesylate for injection is indicated for the treatment of schizophrenia, as monotherapy for the acute treatment of bipolar manic or mixed episodes, and as an adjunct to lithium or valproate for the maintenance treatment of bipolar disorder. Ziprasidone mesylate for injection intramuscular is indicated for acute agitation in schizophrenic patients. When deciding among the alternative treatments available for the condition needing treatment, the prescriber should consider the finding of ziprasidone's greater capacity to prolong the QT/QTc interval compared to several other antipsychotic drugs [see Warnings and Precautions (5.3)] . Prolongation of the QTc interval is associated in some other drugs with the ability to cause torsade de pointes-type arrhythmia, a potentially fatal polymorphic ventricular tachycardia, and sudden death. In many cases this would lead to the conclusion that other drugs should be tried first. Whether ziprasidone will cause torsade de pointes or increase the rate of sudden death is not yet known [see Warnings and Precautions (5.3)] .</IndicationAndUsage>
    <Description>Ziprasidone mesylate for injection is an atypical antipsychotic as an injection (ziprasidone mesylate) for intramuscular use only. Ziprasidone is a psychotropic agent that is chemically unrelated to phenothiazine or butyrophenone antipsychotic agents. It has a molecular weight of 412.94 (free base), with the following chemical name: 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one. The empirical formula of C 21H 21ClN 4OS (free base of ziprasidone) represents the following structural formula:. Ziprasidone mesylate for injection contains a lyophilized form of ziprasidone mesylate trihydrate. Chemically, ziprasidone mesylate trihydrate is 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one, methanesulfonate, trihydrate. The empirical formula is C 21H 21ClN 4OS ∙ CH 3SO 3H ∙ 3H 2O and its molecular weight is 563.09. Ziprasidone mesylate for injection is available in a single-dose vial as ziprasidone mesylate (20 mg ziprasidone/mL when reconstituted according to label instructions) [ see Dosage and Administration (2.4) ]. Each mL of ziprasidone mesylate for injection (when reconstituted) contains 20 mg of ziprasidone and 4.7 mg of methanesulfonic acid solubilized by 294 mg of sulfobutylether β-cyclodextrin sodium (SBECD).</Description>
  </NDC>
  <NDC>
    <NDCCode>83257-004-12</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (83257-004-12)  *  20 mL in 1 VIAL, MULTI-DOSE (83257-003-11)  *  20 mL in 1 VIAL (83257-002-11) </PackageDescription>
    <NDC11Code>83257-0004-12</NDC11Code>
    <ProductNDC>83257-004</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ogivri</ProprietaryName>
    <NonProprietaryName>Trastuzumab-dkst</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20231001</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761074</ApplicationNumber>
    <LabelerName>Biocon Biologics Inc.</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-08-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231001</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ogivri is a HER2/neu receptor antagonist indicated in adults for: 1 The treatment of HER2-overexpressing breast cancer. (1.1, 1.2), 2 The treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. (1.3).</IndicationAndUsage>
    <Description>Trastuzumab-dkst is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. Trastuzumab-dkst is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture. Ogivri (trastuzumab-dkst) for injection is a sterile, off-white to pale yellow, preservative-free lyophilized powder with a cake-like appearance, for injection, for intravenous administration. Each multiple-dose vial of Ogivri delivers 420 mg trastuzumab-dkst, D-sorbitol (322.6 mg), L-Histidine (6.0 mg), Histidine hydrochloride monohydrate (9.4 mg) and Polyethylene glycol 3350/Macrogol 3350 (94.1 mg).  Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer. Reconstitution with 20 mL of the appropriate diluent (BWFI or SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 20 mL (420 mg trastuzumab-dkst), at a pH of approximately 6. If Ogivri is reconstituted with SWFI without preservative, the reconstituted solution is considered single-dose. Each single-dose vial of Ogivri delivers 150 mg trastuzumab-dkst, D-sorbitol (115.2 mg), L-Histidine (2.16 mg), L-Histidine hydrochloride monohydrate (3.36 mg) and Polyethylene glycol 3350/Macrogol 3350 (33.6 mg).  Hydrochloric acid or sodium hydroxide may be used to adjust the pH of the formulation buffer.  Reconstitution with 7.4 mL of sterile water for injection (SWFI) yields a solution containing 21 mg/mL trastuzumab-dkst that delivers 7.15 mL (150 mg trastuzumab-dkst), at a pH of approximately 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>71241-001-01</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (71241-001-01)  &gt; 1 g in 1 TUBE (71241-001-96) </PackageDescription>
    <NDC11Code>71241-0001-01</NDC11Code>
    <ProductNDC>71241-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SIENTRA, INC.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71241-001-10</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-001-10)  &gt; 10 g in 1 BOTTLE, PUMP (71241-001-97) </PackageDescription>
    <NDC11Code>71241-0001-10</NDC11Code>
    <ProductNDC>71241-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SIENTRA, INC.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71241-001-20</NDCCode>
    <PackageDescription>20 g in 1 BOTTLE, PUMP (71241-001-20) </PackageDescription>
    <NDC11Code>71241-0001-20</NDC11Code>
    <ProductNDC>71241-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SIENTRA, INC.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-20</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>71241-001-50</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-001-50)  &gt; 50 g in 1 BOTTLE, PUMP (71241-001-99) </PackageDescription>
    <NDC11Code>71241-0001-50</NDC11Code>
    <ProductNDC>71241-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160309</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SIENTRA, INC.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71241-001-98</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-001-98)  &gt; 20 g in 1 BOTTLE, PUMP (71241-001-20) </PackageDescription>
    <NDC11Code>71241-0001-98</NDC11Code>
    <ProductNDC>71241-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>SIENTRA, INC.</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>BIOCORNEUM® can reduce the appearance of scars and is ideal for use on any intact skin surface, including skin that flexes (such as joints) and areas exposed to sun (such as the face and hands).</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71241-002-99</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-002-99)  &gt; 5 g in 1 BOTTLE, PUMP (71241-002-05) </PackageDescription>
    <NDC11Code>71241-0002-99</NDC11Code>
    <ProductNDC>71241-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Advanced Scar Treatment Anti-itch</ProprietaryName>
    <NonProprietaryName>Hydrocortisone Acetate 1%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20180508</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part348</ApplicationNumber>
    <LabelerName>Sientra, Inc.</LabelerName>
    <SubstanceName>HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180508</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71241-003-96</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-003-96)  &gt; 1 g in 1 BOTTLE, PUMP (71241-003-01) </PackageDescription>
    <NDC11Code>71241-0003-96</NDC11Code>
    <ProductNDC>71241-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sientra, Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71241-003-97</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-003-97)  &gt; 10 g in 1 BOTTLE, PUMP (71241-003-10) </PackageDescription>
    <NDC11Code>71241-0003-97</NDC11Code>
    <ProductNDC>71241-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sientra, Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-12-29</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71241-003-98</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-003-98)  &gt; 20 g in 1 BOTTLE, PUMP (71241-003-20) </PackageDescription>
    <NDC11Code>71241-0003-98</NDC11Code>
    <ProductNDC>71241-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sientra, Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>71241-003-99</NDCCode>
    <PackageDescription>1 BOTTLE, PUMP in 1 CARTON (71241-003-99)  &gt; 50 g in 1 BOTTLE, PUMP (71241-003-50) </PackageDescription>
    <NDC11Code>71241-0003-99</NDC11Code>
    <ProductNDC>71241-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName>
    <NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200331</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Sientra, Inc</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 15; 5; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200331</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>0004-0086-94</NDCCode>
    <PackageDescription>168 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0004-0086-94) </PackageDescription>
    <NDC11Code>00004-0086-94</NDC11Code>
    <ProductNDC>0004-0086</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Copegus</ProprietaryName>
    <NonProprietaryName>Ribavirin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20021203</StartMarketingDate>
    <EndMarketingDate>20180131</EndMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021511</ApplicationNumber>
    <LabelerName>Genentech, Inc.</LabelerName>
    <SubstanceName>RIBAVIRIN</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nucleoside Analog [Chemical/Ingredient],Nucleoside Analog Antiviral [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-02-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>0024-5908-01</NDCCode>
    <PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-01)  / 1.14 mL in 1 SYRINGE (0024-5908-00) </PackageDescription>
    <NDC11Code>00024-5908-01</NDC11Code>
    <ProductNDC>0024-5908</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kevzara</ProprietaryName>
    <NonProprietaryName>Sarilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170522</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761037</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>SARILUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1.14mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170522</StartMarketingDatePackage>
    <EndMarketingDatePackage>20270430</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
    <Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5908-02</NDCCode>
    <PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5908-02)  / 1.14 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00024-5908-02</NDC11Code>
    <ProductNDC>0024-5908</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kevzara</ProprietaryName>
    <NonProprietaryName>Sarilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170522</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761037</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>SARILUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1.14mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
    <Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5910-01</NDCCode>
    <PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5910-01)  / 1.14 mL in 1 SYRINGE (0024-5910-00) </PackageDescription>
    <NDC11Code>00024-5910-01</NDC11Code>
    <ProductNDC>0024-5910</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kevzara</ProprietaryName>
    <NonProprietaryName>Sarilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170522</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761037</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>SARILUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1.14mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
    <Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5910-02</NDCCode>
    <PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5910-02)  / 1.14 mL in 1 SYRINGE</PackageDescription>
    <NDC11Code>00024-5910-02</NDC11Code>
    <ProductNDC>0024-5910</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kevzara</ProprietaryName>
    <NonProprietaryName>Sarilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170522</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761037</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>SARILUMAB</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1.14mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170522</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
    <Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
  </NDC>
  <NDC>
    <NDCCode>0024-5920-01</NDCCode>
    <PackageDescription>2 SYRINGE in 1 PACKAGE (0024-5920-01)  / 1.14 mL in 1 SYRINGE (0024-5920-00) </PackageDescription>
    <NDC11Code>00024-5920-01</NDC11Code>
    <ProductNDC>0024-5920</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kevzara</ProprietaryName>
    <NonProprietaryName>Sarilumab</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>SUBCUTANEOUS</RouteName>
    <StartMarketingDate>20170522</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA761037</ApplicationNumber>
    <LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
    <SubstanceName>SARILUMAB</SubstanceName>
    <StrengthNumber>150</StrengthNumber>
    <StrengthUnit>mg/1.14mL</StrengthUnit>
    <Pharm_Classes>Interleukin 6 Receptor Antagonists [MoA], Interleukin-6 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-03-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180413</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KEVZARA® is an interleukin-6 (IL-6) receptor antagonist indicated for treatment of: 1 adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). (1.1), 2 adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper. (1.2), 3 patients who weigh 63 kg or greater with active polyarticular juvenile idiopathic arthritis (pJIA). (1.3).</IndicationAndUsage>
    <Description>Sarilumab is a human recombinant monoclonal antibody of the IgG1 subclass that binds to the IL-6 receptor and has an approximate molecular weight of 150 kDa. Sarilumab is produced by recombinant DNA technology in Chinese Hamster Ovary cell suspension culture. KEVZARA (sarilumab) injection for subcutaneous administration is supplied as a sterile, clear and colorless to pale yellow, preservative-free solution of approximately pH 6.0. KEVZARA is supplied in a single-dose pre-filled syringe and pre-filled pen. Each syringe or pen delivers 1.14 mL of solution containing 150 mg or 200 mg of sarilumab, arginine (8.94 mg), histidine (3.71 mg), polysorbate 20 (2.28 mg), sucrose (57 mg) and Water for Injection, USP.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>71241-004-94</NDCCode><ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment Gel</ProprietaryName><NonProprietaryName>Avobenzone,homosalate,meradimate,octisalate,octocrylene</NonProprietaryName></NDC><NDC><NDCCode>14498-004-01</NDCCode><ProprietaryName>Sterile Cord Blood Collection Unit (msc128d)</ProprietaryName><NonProprietaryName>Anticoagulant Citrate Phosphate Dextrose Solution</NonProprietaryName></NDC><NDC><NDCCode>24562-004-30</NDCCode><ProprietaryName>Ammonia N 13</ProprietaryName><NonProprietaryName>Ammonia N-13</NonProprietaryName></NDC><NDC><NDCCode>43674-004-02</NDCCode><ProprietaryName>Rezenopy</ProprietaryName><NonProprietaryName>Naloxone Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51655-004-20</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>51655-004-52</NDCCode><ProprietaryName>Minocycline Hydrochloride</ProprietaryName><NonProprietaryName>Minocycline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>62332-004-90</NDCCode><ProprietaryName>Pramipexole Dihydrochloride</ProprietaryName><NonProprietaryName>Pramipexole Dihydrochloride</NonProprietaryName></NDC><NDC><NDCCode>74204-004-01</NDCCode><ProprietaryName>Nelsons Green Brier Hand Rub</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>78740-004-04</NDCCode><ProprietaryName>Ivresse Sanitizer Disinfectant</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>80933-004-01</NDCCode><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>80933-004-02</NDCCode><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>82449-004-01</NDCCode><ProprietaryName>Ziprasidone Mesylate</ProprietaryName><NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName></NDC><NDC><NDCCode>82449-004-02</NDCCode><ProprietaryName>Ziprasidone Mesylate</ProprietaryName><NonProprietaryName>Ziprasidone Mesylate</NonProprietaryName></NDC><NDC><NDCCode>83257-004-12</NDCCode><ProprietaryName>Ogivri</ProprietaryName><NonProprietaryName>Trastuzumab-dkst</NonProprietaryName></NDC><NDC><NDCCode>71241-001-01</NDCCode><ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>71241-001-10</NDCCode><ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>71241-001-20</NDCCode><ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>71241-001-50</NDCCode><ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>71241-001-98</NDCCode><ProprietaryName>Biocorneum Plus Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Octinoxate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>71241-002-99</NDCCode><ProprietaryName>Biocorneum Advanced Scar Treatment Anti-itch</ProprietaryName><NonProprietaryName>Hydrocortisone Acetate 1%</NonProprietaryName></NDC><NDC><NDCCode>71241-003-96</NDCCode><ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName></NDC><NDC><NDCCode>71241-003-97</NDCCode><ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName></NDC><NDC><NDCCode>71241-003-98</NDCCode><ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName></NDC><NDC><NDCCode>71241-003-99</NDCCode><ProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</ProprietaryName><NonProprietaryName>Biocorneum Plus Broad Spectrum Spf 30 Advanced Scar Treatment</NonProprietaryName></NDC><NDC><NDCCode>0004-0086-94</NDCCode><ProprietaryName>Copegus</ProprietaryName><NonProprietaryName>Ribavirin</NonProprietaryName></NDC><NDC><NDCCode>0024-5908-01</NDCCode><ProprietaryName>Kevzara</ProprietaryName><NonProprietaryName>Sarilumab</NonProprietaryName></NDC><NDC><NDCCode>0024-5908-02</NDCCode><ProprietaryName>Kevzara</ProprietaryName><NonProprietaryName>Sarilumab</NonProprietaryName></NDC><NDC><NDCCode>0024-5910-01</NDCCode><ProprietaryName>Kevzara</ProprietaryName><NonProprietaryName>Sarilumab</NonProprietaryName></NDC><NDC><NDCCode>0024-5910-02</NDCCode><ProprietaryName>Kevzara</ProprietaryName><NonProprietaryName>Sarilumab</NonProprietaryName></NDC><NDC><NDCCode>0024-5920-01</NDCCode><ProprietaryName>Kevzara</ProprietaryName><NonProprietaryName>Sarilumab</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
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      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97709-1397",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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